Method and apparatus for radical prostatectomy anastomosis including an anchor for engaging a body vessel and deployable sutures

ABSTRACT

A device for joining a first body vessel to a second body vessel including a cartridge having a distal end and defining a longitudinal axis, a radially expandable anchor disposed at the distal end of the cartridge for engaging the first body vessel, the expandable anchor having an initial condition and an expanded condition wherein the expandable anchor is radially larger than the expandable anchor in the initial condition, and a plurality of sutures disposed within the cartridge and being deployable therefrom so as to engage the second body vessel, the sutures being threaded through the expandable anchor.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is a Divisional Application claiming the benefitof and priority to U.S. application Ser. No. 10/550,705, filed on Sep.27, 2005, which is a U.S. National Phase filing under 35 U.S.C. 371 ofInternational Application Serial No. PCT/US03/11914, filed on Apr. 16,2003, the entire content of each of which being incorporated herein byreference.

BACKGROUND

1. Technical Field

The present disclosure relates an apparatus and methods for anastomosingtwo hollow body parts and, more particularly to apparatus and methodsfor anastomosing a urethral stump of a patient to the bladder followinga radical prostatectomy.

2. Background of Related Art

Most body conduits are generally cylindrical in configuration and have acircular cross-section. When it is desired to suture such a conduit,typically for attachment to another body conduit, sutures are placedaround the circumference of the conduit in order to maintain the patencyof its lumen or channel. This type of attachment is commonly referred toas an anastomosis. It can be appreciated that the sutures made on top ofthe conduit (i.e., on the side facing the surgeon) in an anastomosis aremade relatively more easily than the sutures made underneath the conduit(i.e., on the side facing away from the surgeon). The complexity ofanastomosis attachment is made manifestly apparent in a surgicalprocedure referred to generally as a radical prostatectomy (i.e., a wellestablished surgical procedure for patients with localized prostaticcarcinoma). In general, radical prostatectomy procedures require theremoval of cancerous tissue while preserving sexual function andcontinence in the patient. There are two primary types of radicalprostatectomy approaches for the removal of prostate cancer, theretropubic approach and the perineal approach.

In the retropubic approach, a long up-and-down incision is made in themidline of the abdomen from the navel to the pubic bone. After the lymphnodes have been removed for study by the pathologist and a determinationhas been made to proceed with the removal of the prostate gland, thespace underneath the pubic bone is cleaned and dissected and the removalof the entire prostate gland is generally begun at the end that isfarthest from the bladder, i.e., next to the external urethralsphincter. Next, the prostatic urethra is divided, the prostatic urethraand the prostate gland through which it goes are then pulled upwardstoward the bladder while the dissection continues behind the prostategland, separating it from the layer of tissue that is connected to therectum on its other side. As the dissection continues between theprostate and the rectum, the seminal vesicles, which are behind the baseof the bladder will be removed along with the prostate gland. Once theseminal vesicles are free, the entire prostate gland and the seminalvesicles are removed. The bladder neck is then stitched closed to asmall enough diameter so that it is about the same size as the stump ofthe urethra from which the prostate was detached. The bladder neck isthen pulled down into the pelvis and positioned against the urethralstump and stitched thereto. This stitching is done typically around aFoley catheter which has been inserted through the penis all the wayinto the bladder.

In the perineal approach, an inverted “U” shaped incision is made goingright over the anus, with the center of the “U” about three centimetersabove the margin of the anus. The prostate gland is then freed from itssurrounding structures by gentle dissection, and the urethra at the endof the prostate farthest from the bladder is isolated and divided. Thebladder neck is freed from the prostate, and, once the prostate glandhas been removed and the bladder neck has been closed sufficiently sothat the size of its opening approximates the size of the urethralopening, the urethra and the bladder neck are stitched together. Onceagain, a Foley catheter is left in place postoperatively for about twoweeks.

In each of the above described procedures, it is the attachment of theurethral stump to the bladder neck which is particularly difficult andcomplex. This difficulty is complicated by the tendency of the urethralstump to retract into adjacent tissue. As a result, considerable timeand effort must be expended to re-expose the urethral stump and beginthe re-anastomosis procedure. Further complicating this procedure is thefact that the urethral stump is hidden beneath the pubic bone thusrequiring that the surgeon work at a difficult angle and in positionsthat are uncomfortable and limiting.

Various devices have been proposed for facilitating this procedure. InU.S. Pat. No. 5,591,179, issued to Edelstein, there is disclosed asuturing device including a shaft with portions defining an interiorchannel extending between a proximal and a distal end of the shaft. Thischannel includes a generally axial lumen which extends to the proximalend of the shaft and a generally transverse lumen which extends from theaxial lumen distally outwardly to an exit hole at the outer surface ofthe shaft. A needle and suture can be back loaded into the transverselumen of the channel while a generally non-compressible member can bemovably mounted in the axial lumen of the channel. At the proximal endof the shaft a handle is provided with means operative to push themember distally through the lumen to deploy or expel the needle.

In U.S. Pat. No. 4,911,164, issued to Roth, there is disclosed a sutureguide with a curved distal portion. The distal portion of the sutureguide has a plurality of exterior axial grooves which can be used toalign and guide a curved needle and attached suture. In order to drivethe urethral stump to an accessible position, the device is providedwith a plurality of outwardly extendable members which engage the lumenof the urethra. These members make it possible to push the urethralstump into approximation with the bladder neck.

In U.S. Pat. No. 5,047,039, issued to Avant et al., there is disclosed asurgical device for the ligation of a dorsal vein and subsequentanastomosis. This device contains a pair of enclosed needles each havingan attached suture which needles may be driven from the shaft of thedevice into adjacent tissue.

In general, none of the devices disclosed in the prior art referencesabove is simple to use or makes the anastomosis of the urethral stump tothe bladder neck easier. As such, each surgical procedure using theprior art devices continues to be time consuming and to require greatskill. In addition, these prior art references do not disclose a suturedevice which can accurately position a plurality of anchor and suturecombinations, for use at or near the severed end of a body conduit,simultaneously. Accordingly, the need exists for radical prostatectomyanastomosis devices which overcome the drawbacks of the prior artdevices and which are quick and simple to use.

SUMMARY

Devices and methods for performing a surgical anastomotic procedure aredisclosed herein.

According to one aspect of the present disclosure, a device for joininga first body vessel to a second body vessel is provided including acartridge having a distal end and defining a longitudinal axis, aradially expandable anchor disposed at the distal end of the cartridgefor engaging the first body vessel, the expandable anchor having aninitial condition and an expanded condition wherein the expandableanchor is radially larger than the expandable anchor in the initialcondition, and a plurality of sutures disposed within the cartridge andbeing deployable therefrom so as to engage the second body vessel, thesutures being threaded through the expandable anchor.

The expandable anchor includes a plurality of flexible arms biased in anexpanded position. The cartridge includes an inner member and an outermember having a lumen dimensioned to receive the inner member, thesutures being disposed in channels formed in the inner member.

The anchor has a central passage and the sutures extend through theexpandable anchor and proximally through the central passage. Theexpandable anchor is disposed between the inner member and the outermember. The sutures desirably have distal ends and needle anchorsattached to the distal ends, the needle ends being deployable from thecartridge.

It is envisioned that the device further includes a ring disposed withinthe outer member for securing the sutures to the expandable anchor. Theexpandable anchor desirably includes a plurality of holes, each of theholes receiving one of the sutures. The expandable anchor includes aplurality of arms connected by members.

The inner member desirably includes a ring having connection featuresfor engaging the arms. It is envisioned that the ring, expandable anchorand members are sized so that when the ring engages the arms, themembers are broken and the arms remain attached to the ring. The innermember has a tapered distal end.

According to another aspect of the present disclosure, a device forjoining a first body vessel to a second body vessel is provided andincludes a cartridge having a distal end and defining a longitudinalaxis, an anchor disposed at the distal end of the cartridge for engagingthe first body vessel, and a plurality of sutures disposed within thecartridge and being deployable therefrom so as to engage the second bodyvessel, the sutures being threaded through the anchor.

The anchor includes a plurality of outwardly extending arms. Thecartridge includes an inner member and an outer member having a lumendimensioned to receive the inner member, the sutures being disposed inchannels formed in the inner member. The outer member and anchor aresized so that the anchor is disposed along the longitudinal axis withinthe outer member. The anchor has a central passage and the suturesextend through the anchor and proximally through the central passage.The sutures have distal ends and needle anchors attached to the distalends, the needles being deployable from the cartridge.

The device further includes a ring disposed within the outer member forsecuring the sutures to the expandable anchor.

The anchor includes a plurality of holes, each of the holes receivingone of the sutures.

According to a still further aspect of the present disclosure, anapparatus for performing a surgical anastomosis is provided and includesa sleeve having a proximal and a distal end and defining a longitudinalaxis and a tubular body configured and adapted to be slidably receivedwithin the sleeve, the tubular body defining a central lumen extendinglongitudinally therethrough.

The apparatus further includes a firing head operatively coupled to adistal end of the tubular body. The firing head has a recess co-axiallyaligned and interconnected with the central lumen of the tubular body.The firing head further includes at least one needle passage formedtherein and extending into the central lumen of the tubular body.

The apparatus includes an anchor configured and adapted to be receivedwithin the distal end of the sleeve. The anchor has a hub, a pluralityof resilient arms extending from the hub and an annular flange extendingfrom a proximal surface of the hub. Each of the plurality of arms has afirst position in axial alignment with the longitudinal axis of thesleeve and a second position orthogonal to the longitudinal axis of thesleeve. The anchor further includes a central passage extending throughthe hub and the annular flange.

The apparatus further includes a needle pusher assembly having at leastone push rod slidably received within a respective needle passage. Alock collar is provided which is configured and adapted to be tightlyfit in the central passage of the anchor. The lock collar is held withinthe recess of the firing head by at least one break-away tab extendingfrom an outer surface of the lock collar to an inner surface of therecess of the firing head.

The apparatus includes at least one needle anchor having a suturesecured thereto. The at least one needle anchor is slidably received ina respective needle passage. The suture runs from the at least oneneedle anchor, out a respective needle passage, into the central passageof the anchor through a respective hole formed in the flange, proximallyinto the recess of the firing head, between the lock collar and thefiring head and proximally through the central lumen of the tubularbody.

A method of performing a surgical anastomotic procedure, using theapparatus disclosed above is provided and includes providing apparatusas disclosed above, loading the distal end of the sleeve with the anchorsuch that each of the plurality of arms of the anchor are in the firstposition, passing the apparatus through a body lumen until the anchor ispositioned entirely within a body vessel, deploying the anchor bywithdrawing the sleeve proximally so that the arms are in the secondposition, withdrawing the sleeve and tubular body proximally through thebody lumen until the needle passages are within the body lumen, firingthe needle anchors through the body lumen by driving the push rods ofthe pusher assembly distally through the central lumen of the tubularbody, approximating the body vessel to the body lumen by pulling on theat least one suture, holding the at least one suture in place, advancingthe tubular body through the body lumen and fitting the lock collar intothe flange of the anchor to thereby fix the at least one suture inplace.

The method further includes the steps of removing the prostate gland,freeing the urethra from the prostate gland to thereby define a urethralstump, and freeing the prostate gland from the bladder to define abladder neck,

The presently disclosed anastomosis devices and apparatus, together withattendant advantages, will be best understood by reference to thefollowing detailed description in conjunction with the figures below.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the disclosureand, together with the general description given above, and the detaileddescription of the embodiments given below, serve to explain theprinciples of the present disclosure.

FIG. 1A is a perspective view of an embodiment of a distal end view ofan anastomosis apparatus, in accordance with the present disclosure,shown in an insertion position;

FIG. 1B is a perspective view of the apparatus of FIG. 1, shown in adeployed position;

FIG. 2A is a cross-sectional side elevational view showing the apparatusaccording to the present disclosure as shown in FIG. 1A, insertedthrough a body lumen and into a hollow body organ;

FIG. 2B is a cross-sectional side elevational view showing the apparatusaccording to the present disclosure as shown in FIG. 1A, insertedthrough a body lumen and further into a hollow body organ;

FIG. 2C is a cross-sectional side elevational view of the apparatus asshown in FIG. 1B, with an expandable anchor in accordance with thepresent disclosure, deployed within the hollow body organ and needleanchors being fired into the body lumen;

FIG. 2D is a cross-sectional side elevational view of the apparatus asshown in FIG. 1B, with the needle anchors secured to the body lumen;

FIG. 2E is a cross-sectional side elevational view of the apparatus asshown in FIG. 1B, illustrating the approximation of the hollow bodyorgan to the body lumen;

FIG. 2F is a cross-sectional side elevational view of the apparatus asshown in FIG. 1B, following the surgical procedure, with the sleeve andthe tubular body removed from the operative site;

FIG. 3A is a perspective view of a distal end view of another embodimentof an anastomosis apparatus in accordance with the present disclosure;

FIG. 3B is a cross-sectional side elevational view showing the apparatusof FIG. 3A, inserted through a body lumen and into a body organ;

FIG. 3C is a cross-sectional side elevational view showing the apparatusof FIG. 3A, with the body organ approximated to the body lumen;

FIG. 4A is a perspective view of a distal end view of an additionalembodiment of the anastomosis apparatus, in accordance with the presentdisclosure, inserted through a body lumen; and

FIG. 4B is a perspective view of the apparatus shown in FIG. 4Aillustrating the approximation of the body lumen with a body organ.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Preferred embodiments of the presently disclosed apparatus forperforming an anastomosis will now be described in detail with referenceto the drawing figures wherein like reference numerals identify similaror identical elements. In the drawings and in the description whichfollows, the term “proximal”, as is traditional will refer to the end ofthe surgical device or instrument of the present disclosure which isclosest to the operator, while the term “distal” will refer to the endof the device or instrument which is furthest from the operator.

Referring to FIGS. 1A to 2F, and in particular to FIGS. 1A and 1B, ananastomosis apparatus in accordance with the present disclosure, isshown generally as reference numeral 100. Although apparatus 100 offerssignificant advantages to a radical prostatectomy procedure, it will beunderstood that the device is applicable for use in any anastomoticprocedure where two body vessels are to be secured to one another, suchas where the end of a conduit is to be sutured or otherwise secured to ahollow body organ.

As seen in FIGS. 1A and 1B, apparatus 100 includes a sleeve 10 (inphantom), a tubular body 20 slidably received within sleeve 10 and anexpandable anchor 30 received within a distal end 12 of sleeve 10.Sleeve 10 defines a central longitudinal axis “X”.

Expandable anchor 30 includes a hub 32, a plurality of resilient arms 34extending radially from hub 32 and an annular flange 36 extending from aproximal surface of hub 32. Hub 32 and flange 36 define a centralpassage 38 extending completely therethrough. Flange 36 includes aplurality of holes 40 formed radially therethrough. Preferably, hub 32has a radius which is less than the radius of sleeve 10. In addition,annular flange 36 has a radius which is less than the radius of hub 32.

In accordance with the present disclosure, arms 34 can be biased from afirst radially extended orientation, as seen in FIG. 1B, to a seconddeflected orientation, as seen in FIG. 1A, wherein arms 34 are axiallyaligned with the longitudinal “X” axis and do not extend beyond theradius of sleeve 10. While arms 34 have been shown as generallyrectangular in shape, it is envisioned that arms 34 may assume otherconfigurations including, but not limited to, circular, triangular, etc.

Tubular body 20 includes a needle firing head 60 operatively coupled toa distal end thereof and a central lumen 62 extending completely throughtubular body 20 and firing head 60. A plurality of radially orientedneedle passages 64 are formed in firing head 60 and extend into centrallumen 62. Preferably, needle passages 64 are oriented in a distaldirection.

Firing head 60 further includes a recess 66 co-axially formed in aproximal end thereof (see FIG. 2A). Recess 66 of firing head 60 isconfigured and adapted to retain a lock collar 50 therein. Preferably,lock collar 50 has an external radius which is slightly smaller than aninternal radius of flange 36 of anchor expandable anchor 30. In thismanner, lock collar 50 tightly fits into flange 36, thereby creating afriction fit type coupling. Recess 66 of firing head 60 has an internalradius which is larger than the external radius of lock collar 50. Lockcollar 50 can be provided with an annular rim 54 (see FIG. 2C) formedalong the outer surface thereof. It is envisioned that annular rim 54 isto be received in and mate with an annular channel 56 (see FIG. 2C)formed in the inner surface of flange 36. In this manner, in addition tothe friction fit type coupling, when lock collar 50 is received inflange 36, annular rim 54 snaps into annular channel 56, thereby furthersecuring lock collar 50 in flange 36 thereby also providing the userwith a tactile feel as to when lock collar 50 is properly and fullyreceived within flange 36.

It is envisioned that lock collar 50 is retained in recess 66 by aplurality of break-away tabs 52 which interconnect lock collar 50 andfiring head 60 (see FIG. 2C). The internal radius of recess 66 isselected such that lock collar 50 is centrally suspended therein bybreak-away tabs 52 thereby defining a plurality of passages 58 (see FIG.2C) between lock collar 50 and recess 66.

In accordance with the present disclosure, apparatus 100 furtherincludes a needle pusher assembly 70 (see FIG. 2A). Pusher assembly 70includes a plurality of push rods 72 operatively coupled to one anotherat a proximal end thereof and slidably disposed within central lumen 62of tubular body 20. Push rods 72 have a distal end 74 which is orientedto be received within needle passages 64. Preferably, pusher assembly 70includes a push rod 72 for each needle passage 64. It is envisioned thatpush rods 72 are made from a resilient material in order to permitdeflection of push rods 72 and have sufficient rigidity in order toresist compressive forces acting thereon. In accordance with the presentdisclosure, as pusher assembly 70 is advanced distally through centrallumen 62, push rods 72 slide through a respective needle passage 64.

Push rods 72 may be arranged as disclosed in commonly assigned U.S.Patent Application entitled “Method and apparatus for RadicalProstatectomy Anastomosis Including an Anchor for Engaging a Body Vesseland Deployable Sutures”, invented by Scott Manzo and filed on an evendate herewith, the disclosure of which is hereby incorporated byreference herein in its entirety.

Apparatus 100 further includes a plurality of needle anchors 80 slidablyreceived within needle passages 64. Each needle anchor 80 is providedwith a suture 82 having a first end preferably affixed to a mid-point ofa respective needle anchor 80 and a second end affixed to a commonhandle 84. In accordance with the present disclosure, each suture 82runs from a respective needle anchor 80, distally out of a respectiveneedle passage 64, into central passage 38 of flange 36 through arespective hole 40, proximally into recess 66 of firing head 60, throughpassages 58 between lock collar 50 and firing head 60 and proximallythrough central lumen 62 of tubular body 20 to handle 84.

Preferably, expandable anchor 30, lock collar 50, needle anchors 80 andsutures 82 are made from a medical grade bio-absorbable material, suchas, for example, polyglycolic acid (PGA) and/or polylactic acid (PLA).It is envisioned that expandable anchor 30, lock collar 50, needleanchors 80 and sutures 82 have sufficient endurance to retain theirstructural integrity for at least the period required for a naturalgrowth joining of tissue portions for a given anastomotic procedure.

A preferred method of use and operation of anastomosis apparatus 100 inperforming a radical prostatectomy anastomosis will now be described ingreater detail with reference to FIGS. 1A-2F and in particular withreference to FIGS. 2A-2F. Apparatus 100 can be used in either theretropubic or the perineal prostatectomy approaches. With the prostateremoved, the bladder neck “N” of the bladder “B” is first reconstructedby everting the inner mucosal lining of bladder “B” and suturing it downto the outer wall of bladder “B”, using known surgical techniques.Likewise, urethral stump “S” of urethra “U” is reconstructed by evertingthe inner mucosal lining of urethral stump “S” and suturing it down tothe outer wall of urethra “U”, using known surgical techniques.

Preferably, with bladder neck “N” reconstructed, bladder neck “N” issized to properly accommodate expandable anchor 30 within bladder “B”using a standard tennis racket type closure (i.e., the opening of thebladder neck constituting the head of the tennis racket and a radialincision extending from the bladder neck constituting the handle portionof the tennis racket). Most preferably, bladder neck “N” is sized to beapproximately 7-8 mm in diameter.

With bladder neck “N” reconstructed, apparatus 100 is passedtrans-urethrally through urethra “U” until the distal end of sleeve 10extends out of urethra “U” and into bladder “B”, as seen in FIG. 2A. Inparticular, as seen in FIG. 2B, apparatus 100 is positioned such thatbiased arms 34 of expandable anchor 30 are located entirely withinbladder “B”. With apparatus 100 so positioned, sleeve 10 is withdrawnproximally while tubular body 20 is maintained stationary. Accordingly,as sleeve 10 passes the ends of arms 34, arms 34 are automaticallybiased to the radially extended orientation, as seen in FIG. 2C.

With continued reference to FIG. 2C, sleeve 10 and tubular body 20 arethen withdrawn proximally into urethra “U” until needle passages 64 arewithin urethra “U”. Sleeve 10 is then withdrawn proximally until needlepassages 64 are exposed. With needle passages 64 exposed, needle pusherassembly 70 is advanced distally through tubular body 20. As such, thedistal ends of push rods 72 abut against needle anchors 80 therebyforcing needle anchors 80 through urethral stump “S”. Pusher assembly 70is advanced distally until push rods 72 push needle anchors 80completely through urethral stump “S”. Preferably, each needle anchor 80includes a pointed tip which aides in the penetration of needle anchors80 into urethral stump “S”. Following the anchoring of needle anchors 80to urethral stump “S”, pusher assembly 70 is withdrawn proximally intotubular body 20 at least until the distal ends of each push rod 72 iswithin tubular body 20 (see FIG. 2D).

In particular, as seen in FIG. 2D, handle 84 is drawn proximally, in adirection “C”, thereby pulling on sutures 82. Since needle anchors 80are secured in place in urethral stump “S” and since expandable anchor30 is securely held within bladder “B” by arms 34, pulling on orapplying tension to sutures 82, in direction “C” will cause sutures 82extending between urethra “U” and bladder “B” to shorten, therebyapproximating bladder neck “N” of bladder “B” to urethral stump “S” ofurethra “U”. In particular, pulling on handle 84 in direction “C” drawssutures 82 through central lumen 62 of tubular body 20, through recess66, through passages 58 between lock collar 50 and firing head 60,through central passage 38 of flange 36, through a respective hole 40,between bladder neck “N” and flange 36 and through urethral stump “S”where it is secured to a respective needle anchor 80. Since needleanchors 80 are prevented from coming through urethral stump “S”, pullingon handle 84 will cause bladder “B” to be moved in direction “C” andultimately in the approximation of bladder neck “N” to urethral stump“S”, as seen in FIG. 2E.

With bladder neck “N” approximated to urethral stump “S”, handle 84 isheld, thereby keeping sutures 82 under tension, and tubular body 20 ismoved distally in direction “D” (i.e., opposite direction “C”). Tubularbody 20 is advanced distally until lock collar 50 is inserted intoand/or received in central passage 38 of flange 36. As described above,preferably, lock collar 50 is sized to be tightly fit into flange 36(i.e., friction fit). More preferably, as described above, tubular body20 is advanced distally until lock collar 50 is snap fit into flange 36by the receipt of annular rim 54 into annular channel 56. As seen inFIG. 2F, by having lock collar 50 tightly received in flange 36, theouter surface of lock collar 50 presses against the inner surface offlange 36 thereby squeezing sutures 82 therebetween. In so doing,sutures 82 are prevented from being distally passed through flange 36which would in turn cause bladder “B” to separate from urethra “U”.

With lock collar 50 secured in flange 36, it is envisioned that tubularbody 20 is twisted, thereby breaking break-away tabs 52 in order toseparate lock collar 50 from tubular body 20. Tubular body 20 is thenwithdrawn from sleeve 10. As seen in FIG. 2F, sutures 82 are then cutand sleeve 10 withdrawn from urethra “U”.

It is contemplated that additional clips, staples, sutures and/or otherfastening devices may or may not be used to join urethra “U” and bladder“B” together.

Referring now to FIGS. 3A-3C, another embodiment of an anastomosisapparatus, in accordance with the present disclosure, is shown generallyas 200. Anastomosis apparatus 200 includes an outer sleeve 210, an innertubular body 220, a detachable or repositionable expandable anchor 230,a lock ring 250 and needle anchors 280.

Inner tubular body 220 is slidably received within outer sleeve 210.Inner tubular body 220 has a distal end portion 222 having a firstdiameter and a proximal end portion 224 having a second diameter whichis greater than the first diameter thereby defining a shoulder 225.Inner tubular body 220 includes a central lumen 226 extendingtherethrough defining a longitudinal X-axis. Inner tubular body 220further includes a plurality of longitudinally running firing channels228 formed therein. Preferably, firing channels 228 include a distal endoriented radially outward at an angle which is obtuse to thelongitudinal X-axis. Distal end portion 222 includes a substantiallyconical tip 221.

Expandable anchor 230 includes a plurality of arms 245 and a lock ring250. Each arm 245 has a distal portion 242 oriented substantiallyorthogonal to a longitudinal “X” axis of inner tubular body 220 and aproximal portion 244 oriented substantially linearly with thelongitudinal X-axis. Each distal portion 242 includes at least one toothor spike 243 for engaging the inside wall of the hollow body organ to bejoined. Each proximal portion 244 includes at east one hole 248 formedtherein.

Arms 245 are preferably arranged such that distal portion 242 of eacharm 245 is oriented radially outward. It is envisioned that arms 245 arejoined to one another by a break-away member 246 interconnecting eachproximal portion 244. In accordance with the present disclosure,expandable anchor 230 has a first position in which proximal portions244 are in relatively close proximity to one another and interconnectedby break-away members 246 and a second position in which proximalportions 244 are relatively further spaced from one another and brokenaway from at least one break-away member 246. Stated differently, in thefirst position, proximal portions 244 of expandable anchor 230 arepositioned in relatively close proximity to the central longitudinalX-axis and in the second position, proximal portions 244 of expandableanchor 230 are positioned at a relatively further distance to thecentral longitudinal X-axis.

Preferably, when in the first position, expandable anchor 230 is sizedto be received within outer sleeve 210 and when in the second position,distal end portion 242 extends radially beyond outer sleeve 210 andpreferably beyond the terminal edge of an opening in a hollow bodyorgan. Preferably, arms 245 are formed of a rigid bio-compatiblematerial, however, it is envisioned that arms 245 can be formed of aresilient bio-compatible material. Arms 245 can also have other shapes,other than L-shaped as shown in FIG. 3A. Anchor 230 is shaped/sized tofit within the opening of bladder “B” in the pre-expanded condition toengage bladder “B” in the expanded condition.

In accordance with the present disclosure, lock ring 250 is slidablypositioned on distal end 222 of inner tubular body 220. As best seen inFIG. 3B, lock ring 250 desirably has a substantially trapezoidal radialcross-sectional profile. In particular, lock ring 250 has an angleddistal end defining a caroming surface 252 and a substantially planarproximal surface configured and adapted to contact shoulder 225 of innertubular body 220. Lock ring 250 also includes connection features forconnecting arms 245 to lock ring 250. For example, lock ring 250 mayinclude grooves sized and shaped to engage and retain arms 245 in alocking fashion and may include a lip for locking arms 245 in lock ring250. Other features may be used including adhesives.

Desirably, lock ring 250 is releasably attached to body 220 by any knownmeans. For example, a releasable lever on body 220 may be arranged forengagement with the lock ring and releasable by means of a control at aproximal end of the apparatus. Alternatively, a separate tube may bedisposed around body 220 for sliding lock ring 250 off of body 220.

Apparatus 200 further includes a plurality of needle anchors 280slidably received in the distal end of firing channels 228. Each needleanchor 280 is provided with a suture 282 having a first end preferablyaffixed to a mid-point of a respective needle anchor 280 and a secondend affixed to a handle 284. In accordance with the present disclosure,each suture 282 runs from a respective needle anchor 280, distally outof a respective firing channel 228 through hole 248 formed in proximalportion 244 of a respective arm 245, into a distal end of central lumen226 formed in inner tubular body 220 and proximally therethrough tohandle 284.

Apparatus 200 includes a needle anchor pusher assembly 270. Pusherassembly 270 includes a plurality of push rods 272, preferablyoperatively coupled to one another, slidably disposed within arespective firing channel 228 of inner tubular body 220. Inner tubularbody 220 includes a central lumen 226.

Preferably, expandable anchor 230, lock ring 250, anchor needles 280 andsutures 282 are made from a medical grade bio-absorbable material, suchas, for example, polyglycolic acid (PGA) and/or polylactic acid (PLA).It is envisioned that expandable anchor 230, lock ring 250, anchorneedles 280 and sutures 282 have sufficient endurance to retain theirstructural integrity for at least the period required for a naturalgrowth joining of tissue portions for a given anastomotic procedure.

A preferred method of use and operation of anastomosis apparatus 200 inperforming a radical prostatectomy anastomosis will now be described indetail with reference to FIGS. 3A-3C. With the prostate removed, bladderneck “N” and urethral stump “S” reconstructed, apparatus 200 is passedtrans-urethrally through urethra “U” until the distal end of outersleeve 210 extends out urethral stump “S” and into bladder “B”. Inparticular, apparatus 200 is positioned such that distal portion 242 ofarms 245 are positioned in bladder “B”.

As seen in FIG. 3B, sleeve 210 is withdrawn in a proximal directionuntil distal portion 242 of arms 245 are exposed. Inner tubular body 220is advanced distally until conical tip 221 contacts proximal portion 244of arms 245. Inner tubular body 220 is then further advanced distally,inserting lock ring 250 between arms 245 causing break-away members toseparate from each individual arm 245 thereby causing proximal portion244 of arms 245 to displace radially outward due to the camming actionbetween proximal portions 244 of arms 245 and conical tip 221 of innertubular body 220. Inner tubular body 220 is advanced until proximalportions 244 of arms 245 clear conical tip 221 of inner tubular body andare displaced to a radius substantially equal to the radius of distalend portion 222 of inner tubular body 220. Radial displacement ofproximal portions 244 of arms 245 causes reconstructed bladder neck “N”to radially stretch, thus creating a constricting force acting radiallyinward on proximal portions 244 of arms 245.

It is envisioned that as inner tubular body 220 is advanced distally,arms 245 will cause lock ring 250 to slide proximally along distal endportion 222 of inner tubular body 220. As such, inner tubular body 220is distally advanced until the proximal end of lock ring 250 is stoppedby shoulder 225 of inner tubular body 220. Inner tubular body 220 isfurther advanced distally causing proximal end portion 224 of arms 245to be further displaced radially outward due to the camming actionbetween proximal portions 244 of arms 245 and camming surface 252 oflock ring 250. Arms 245 are enlarged by and attached to lock ring 250.

Outer sleeve 210 and inner tubular body 220 are then withdrawnproximally back through urethral “U”. Accordingly, distal end portion222 of inner tubular body 220 is withdrawn from lock ring 250 which lockring 250 is held in place due to the constricting force of bladder neck“N” pressing into proximal portions 244 of arms 245 which in turn pressinto lock ring 250.

Outer sleeve 210 and inner tubular body 220 are withdrawn proximallyuntil the distal end of firing channels 228 of inner tubular body 220 ispositioned proximally of urethral stump “S”. With inner tubular body 220so positioned, outer sleeve 210 is withdrawn proximally, while innertubular body 220 is held in place, until the distal end of firingchannels 228 are exposed.

Apparatus 200 is then fired by advancing push rods 272 of pusherassembly 270 distally through firing channels 228 thereby forcing needleanchors 280 radially out of firing channels 228. Pusher assembly 270 isdistally advanced until needle anchors 280 completely penetrate throughurethral stump “S”. Push rods 272 are then withdrawn proximally backthrough firing channels 228.

With needle anchors 280 secured in place, as seen in FIG. 3C, sutures282 are withdrawn proximally through central lumen 226 of inner tubularbody 220 by pulling on handle 284. By pulling on handle 284, sutures 282are drawn through holes 248 formed in proximal portion 244 of arms 245,thereby approximating bladder “B” to urethra “U”. By pulling on sutures282 proximally through central lumen 226 of inner tubular body 220,teeth 243 of distal portion 242 of arms 245 digs into the inner surfaceof bladder “B” thereby further securing expandable anchor 230 intoposition. Sutures 282 are then cut and secured in place in order toprevent bladder “B” from separating from urethra “U”.

The sutures may be secured as disclosed in commonly assigned U.S.Application entitled “Method and Apparatus for Radical ProstatectomyAnastomosis Including and Anchor for Engaging a Body Vessel andDeployable Needles”, filed on even date herewith, the disclosure ofwhich is hereby incorporated by reference herein, in its entirety.

Turning now to FIGS. 4A-4B, another embodiment of an anastomosisapparatus, in accordance with the present disclosure, is shown generallyas 300. Apparatus 300 includes a sleeve 310 and a tubular body 320slidably received within sleeve 310. Sleeve 310 and tubular body 320 ofapparatus 300 are substantially similar to sleeve 10, tubular body 20 ofapparatus 100 disclosed above. Accordingly, the detailed description ofsleeve 10 and tubular body 20 of apparatus 100 from above will act asthe detailed description for sleeve 310 and tubular body 320 ofapparatus 300.

In accordance with the present embodiment and as seen in FIGS. 4A and4B, apparatus 300 further includes an anchor 330. Anchor 330 includes aplate 332, a plurality of arms 334 extending radially outward from plate332 and an annular flange 336 extending from a proximal surface of plate332. Preferably, a plurality of arms 334 is desired and more preferably,two pair of equally spaced diametrically opposed arms 334 is desired. Inaccordance with the present embodiment, it is preferred that arms 334are semi-rigid and/or substantially rigid. In this manner, it iscontemplated that arms 334 will not deflect or deform and willsubstantially maintain their configuration when exposed to deformingforces. It is further envisioned that anchor 330 is dimensioned suchthat anchor 330 can be received within sleeve 320.

In addition, plate 332 and flange 336 define a central passage 338extending completely therethrough. Flange 336 includes a plurality ofholes 340 formed radially therethrough.

Apparatus 300 further includes a plurality of needle anchors 380slidably received within a respective needle passage 364 of a firinghead 360 on tubular body 320. Each needle anchor 380 is provided with asuture 382 having a first end affixed to a mid-point of a respectiveneedle anchor and a second end affixed to a common handle 384. Inaccordance with the present disclosure, each suture 382 runs from arespective needle anchor 380, distally out of a respective needlepassage 364, into central passage 338 of flange 336 via a respectivehole 340, proximally into a firing head 360 and proximally through acentral lumen 362 formed in tubular body 320 to handle 384.

Preferably, anchor 330, anchor needles 380 and sutures 382 are made froma medical grade bio-absorbable material, such as, for example,polyglycolic acid (PGA) and/or polylactic acid (PLA). It is envisionedthat anchor 330, anchor needles 380 and sutures 382 have sufficientendurance to retain their structural integrity for at least the periodrequired for a natural growth joining of tissue portions for a givenanastomotic procedure.

A preferred method of use and operation of anastomosis apparatus 300, inperforming a radical prostatectomy anastomosis, will now be described ingreater detail with reference to FIGS. 4A and 4B. With the prostateremoved, bladder neck “N” and urethral stump “S” reconstructed,apparatus 300 is passed trans-urethrally through urethra “U” until thedistal end of outer sleeve 310 extends out urethral stump “S”.

In particular, as seen in FIG. 4A, anchor 330 is then removed from thedistal end of outer sleeve 310 and rotated such that a center linepassing through central passage 338 of anchor 330 is substantiallyorthogonal to the longitudinal X-axis. For example, anchor 330 may beengaged by a surgical device, such as a grasper and rotated by thesurgeon. Anchor 330 is then entirely slipped into bladder “B” throughbladder neck “N” in the manner of a button/button-hole arrangement. Asseen in FIG. 4B, once inserted into bladder “B”, anchor 330 is rotatedin order to substantially align the center line passing through centralpassage 338 of anchor 330 with the longitudinal X-axis. In so doing,arms 334 of anchor 330 extend across bladder neck “N” and beyond theterminal edge of bladder neck “N”, thereby preventing anchor 330 frombeing removed from or pulled out of bladder “B”.

With anchor 330 in position in bladder “B”, apparatus 300, includingsleeve 310 and tubular body 320, is withdrawn proximally through urethra“U” until needle passages 364 are within urethra “U”. With needlepassages 364 exposed, apparatus 300 is fired by advancing needle pushrods (not shown) through tubular body 320 until needle anchors 380 arepushed through the walls of urethral “U”. With needle anchors 380secured to urethra “U”, the needle push rods are then withdrawn fromapparatus 300.

With needle anchors 380 secured to urethra “U”, handle 384 is drawnproximally to thereby pull on and tighten sutures 382. By pullingproximally on handle 384, bladder “B” brought into approximation withurethra “U”. Sutures 282 are then cut and secured in place in order toprevent bladder “B” from separating from urethra “U”.

Although the illustrative embodiments of the present disclosure havebeen described herein with reference to the accompanying drawings, it isto be understood that the disclosure is not limited to theseembodiments, and that various other changes and modifications may beaffected therein by one skilled in the art without departing from thescope or spirit of the disclosure. For example, some or all of thesutures, needle anchors, and expandable anchor are formed frombio-absorbable material or materials. In addition, the needle anchorsmay have other shapes, such as hook-shaped, or any other shape. All suchchanges and modifications are intended to be included within the scopeof the appended claims.

1. A device for joining a first body vessel to a second body vessel,comprising: a) a cartridge having a distal end and defining alongitudinal axis, wherein the cartridge comprises an inner member andan outer member having a lumen dimensioned to receive the inner member;b) a radially expandable anchor disposed at the distal end of thecartridge for engaging the first body vessel, wherein the expandableanchor having a plurality of arms connected by members, wherein theplurality of arms of the expandable anchor have an initial condition andan expanded condition such that in the expanded condition, the pluralityof arms of the expandable anchor extend radially outward, and whereinthe inner member includes a ring having connection features for engagingthe plurality of arms of the radially expandable anchor; c) a pluralityof sutures disposed within the cartridge and being deployable therefromso as to engage the second body vessel, the sutures being disposed inchannels formed in the inner member and threaded through the expandableanchor; and d) a plurality of needle anchors, wherein a needle anchor isattached to a distal end of a respective suture.
 2. The device of claim1, wherein the expandable anchor comprises a plurality of flexible armsbiased in an expanded position.
 3. The device of claim 1, wherein theanchor has a central passage and the sutures extend through theexpandable anchor and proximally through the central passage.
 4. Thedevice of claim 1, wherein the expandable anchor is disposed between theinner member and the outer member.
 5. The device of claim 1, wherein theanchors are deployable from the cartridge.
 6. The device of claim 1,further comprising a ring disposed within the outer member for securingthe sutures to the expandable anchor.
 7. The device of claim 1, whereinthe expandable anchor comprises a plurality of holes, each of the holesreceiving one of the sutures.
 8. The device of claim 1, wherein thering, expandable anchor and members are sized so that when the ringengages the arms, the members are broken and the arms remain attached tothe ring.
 9. The device of claim 1, wherein the inner member has atapered distal end.
 10. A device for joining a first body vessel to asecond body vessel, comprising: a) a cartridge having a distal end anddefining a longitudinal axis, wherein the cartridge comprises an innermember and an outer member having a lumen dimensioned to receive theinner member; b) an anchor disposed at the distal end of the cartridgefor engaging the first body vessel, wherein the anchor includes aplurality of outwardly extending arms, and wherein the outer member andthe anchor are sized so that the anchor is disposed along thelongitudinal axis within the outer member; c) a plurality of suturesdisposed within the cartridge and being deployable therefrom so as toengage the second body vessel, the sutures being disposed in channelsformed in the inner member and threaded through the anchor; and d) aplurality of needle anchors, wherein a needle anchor is attached to adistal end of a respective suture.
 11. The device of claim 10, whereinthe anchor has a central passage and the sutures extend through theanchor and proximally through the central passage.
 12. The device ofclaim 10, wherein the anchors are deployable from the cartridge.
 13. Thedevice of claim 10, further comprising a ring disposed within the outermember for securing the sutures to the expandable anchor.
 14. The deviceof claim 10, wherein the anchor comprises a plurality of holes, each ofthe holes receiving one of the sutures.
 15. A device for joining a firstbody vessel to a second body vessel, the device comprising: a tubularsleeve having a distal end, a proximal end and defining a lumentherethrough; a tubular body slidably disposed within the tubularsleeve; a radially expandable anchor deployably disposed in the distalend of the tubular sleeve at a location distal of the tubular body, theradially expandable anchor being deployable from the distal end of thetubular sleeve, wherein the expandable anchor includes: a hub configuredand dimensioned for disposition in the distal end of the tubular sleeve;and a plurality of resilient arms radially disposed about the hub,wherein the plurality of resilient arms have a collapsed biasedcondition for disposition in the distal end of the tubular sleeve, andan expanded unbiased condition when disposed outside of the distal endof the tubular sleeve; a plurality of needle anchors deployablysupported in a distal end of the tubular body; and a plurality ofsutures, wherein each suture includes a first end connected to arespective one of the plurality of needle anchors, and wherein eachsuture includes a second end extending from a passage of the tubularbody containing the respective needle anchor, through the expandableanchor, and then through a lumen of the tubular body.
 16. The deviceaccording to claim 15, wherein at least a portion of the expandableanchor is disposed between the tubular sleeve and the tubular body. 17.The device according to claim 15, wherein when the plurality ofresilient arms of the expandable anchor are in the collapsed biasedcondition, the plurality of resilient arms extend in a proximaldirection.
 18. The device according to claim 15, further comprising aring disposed within the tubular sleeve for connecting each suture tothe expandable anchor.
 19. A method of joining a first body vessel and asecond body vessel, the method comprising the steps of: providing adevice for joining the first body vessel to the second body vessel, thedevice comprising: a tubular sleeve having a distal end, a proximal endand defining a lumen therethrough; a tubular body slidably disposedwithin the tubular sleeve; a radially expandable anchor deployablydisposed in the distal end of the tubular sleeve at a location distal ofthe tubular body, the radially expandable anchor being deployable fromthe distal end of the tubular sleeve, wherein the expandable anchorincludes: a hub configured and dimensioned for disposition in the distalend of the tubular sleeve; and a plurality of resilient arms radiallydisposed about the hub, wherein the plurality of resilient arms have acollapsed biased condition for disposition in the distal end of thetubular sleeve, and an expanded unbiased condition when disposed outsideof the distal end of the tubular sleeve; a plurality of needle anchorsdeployably supported in a distal end of the tubular body; and aplurality of sutures, wherein each suture includes a first end connectedto a respective one of the plurality of needle anchors, and wherein eachsuture includes a second end extending from a passage of the tubularbody containing the respective needle anchor, through the expandableanchor, and then through a lumen of the tubular body; passing a distalend of the device through the first body vessel and into the second bodyvessel, wherein the expandable anchor is disposed in the distal end ofthe tubular sleeve and the plurality of needle anchors are loaded in thetubular body; withdrawing the tubular sleeve relative to the tubularbody to deploy the expandable anchor to the expanded condition in thesecond body vessel; withdrawing the tubular body such that a distal endthereof is disposed within the first body vessel; firing the pluralityof needle anchors from the tubular body such that the plurality ofneedle anchors penetrate the first body vessel; and withdrawing thesecond end of the plurality of sutures to approximate the first bodyvessel and the second body vessel.